Akorn issues voluntary nationwide recall of various human, animal drug products due to company shutdown
On April 26, Akorn, Inc. announced in a news release that Akorn Operating Company LLC filed Chapter 7 bankruptcy on February 23, 2023. In connection with that filing, the company has ceased and shutdown all operations and terminated all its employees of all domestic U.S. sites.
The Akorn Trustee is initiating a voluntary recall of various within-expiry human and animal products as a result of the closures and discontinuation of the quality activities of these marketed products. The discontinuation of the quality program means the company will not be able to support or guarantee that the products will meet all intended specifications through the labeled shelf life of the product. Further distribution or use of any remaining product on the market should cease immediately.
View the complete list of products, including descriptions, lot number and label in the news release.
The affected products were distributed nationwide to wholesalers, retailers, manufacturers, medical facilities, and repackagers and via the Internet to consumers.
Akorn is notifying its distributors and direct consignees by direct mailing and is requesting they further notify their customers, consumers and retailers. Akorn is requesting destruction of any recalled products. Consumers, distributors and retailers that have products which are being recalled should discard and contact their doctor.
Consumers with questions regarding this recall can contact Akorn at (800) 932-5676 during normal business hours (8am – 5pm CDT) Monday – Friday. A qualified medical professional will return your call within one business day.
Consumers should contact their physician, their healthcare provider or veterinarian if they, or animals in their care, have experienced any problems that may be related to taking or using these drug products.
For human drug products, adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
For animal drug products, adverse reactions or quality problems experienced with the use of animal drug products may be reported to FDA's Center for Veterinary Medicine Adverse Event Reporting program by completing an online Form FDA 1932a available at www.fda.gov/reportanimalae.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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